Role: Manager- Quality Operations
MANDATORY REQUIREMENTS
- Graduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
- 10 to 14 years minimum experience in Quality or Regulatory Affairs
- Experience obtained in pharmaceutical manufacturing sites (+8 years).
- Knowledge of stability regulations and its application to the industry
- Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP.
- English speaker
- Good organizational skills, stress resistance, and flexibility
- Good Team player and positive in decision-making
- Interpretation/Analytical data.
- Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus.
- Reactivity, autonomy with a sense of urgency and priorities.
- Open-mindedness and team spirit.
Position Location:
- Ankleshwar, Zentiva Pvt Ltd, Gujarat, India
ROLE SPECIFICATIONS
Role: Quality Operations
Department: Scientific Affairs
Reports to: Quality & Compliance Manager
Company: Zentiva Quality Operations
PURPOSE OF THE ROLE
Support the Quality Assurance and Compliance function of Zentiva Quality Operations . in order to ensure compliance with Zentiva Quality Operations applicable requirements and Corporate Zentiva guidelines.
The role will be focused in leading a periodic review of products commercialized under the Zentiva Quality Operations authorization.
MAIN RESPONSIBILITIES
- Reporting to Zentiva Quality Operations & Compliance Manager, the Quality Operations Specialist will take lead responsibility for Product Quality Reviews (PQR) review completion for the cases in which Zentiva Quality Operations is marketing authorization holder (MAH).
- Responsible to meet the established schedule in completing the reviews of PQRs.
- For each evaluated PQR the Quality Operations Specialist will ensure that the traceability of the evaluation (report) is always available (document crated, approved/signed and properly archived) according to Zentiva Quality Operations